FDA product code HEP: Monitor, Blood-Flow, Ultrasonic
HEP is the FDA product code for monitor, blood-flow, ultrasonic. It is a Class II device, regulated under 21 CFR 884.2660 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 4 510(k) submissions under HEP, from 4 different applicants. The average 510(k) review took 142 days (median 154).
Classification
| Field | Value |
|---|---|
| Device name | Monitor, Blood-Flow, Ultrasonic |
| Device class | Class II |
| Regulation | 21 CFR 884.2660 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every HEP clearance
Top HEP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Edan Instruments, Inc. | 1 | 2010-08-10 |
| Bionet Company, Ltd. | 1 | 2003-03-03 |
| Ultracell Medical Technologies, Inc. | 1 | 1992-09-15 |
| Imex Medical Systems, Inc. | 1 | 1991-06-24 |
Most recent HEP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K101960 | Edan Instruments, Inc. | SONOTRAX SERIES ULTRASONIC POCKET DOPPLER | 2010-08-10 | 29 |
| K023082 | Bionet Company, Ltd. | BABYCARE | 2003-03-03 | 167 |
| K920353 | Ultracell Medical Technologies, Inc. | ULTRACELL INSTRUMENT WIPE | 1992-09-15 | 232 |
| K910462 | Imex Medical Systems, Inc. | POCKET DOP 3 | 1991-06-24 | 140 |
Recalls for HEP devices
openFDA lists no recalls for product code HEP.
Frequently asked questions
What is FDA product code HEP?
HEP is the FDA product code for monitor, blood-flow, ultrasonic. It is a Class II device, regulated under 21 CFR 884.2660 and reviewed by the Obstetrics and Gynecology panel.
What device class is HEP?
Class II, regulation 21 CFR 884.2660. Typical premarket route: 510(k).
How long does a 510(k) take for product code HEP?
Across 4 cleared submissions the average was 142 days from receipt to decision (median 154).
Which companies have the most HEP clearances?
Edan Instruments, Inc. (1); Bionet Company, Ltd. (1); Ultracell Medical Technologies, Inc. (1); Imex Medical Systems, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HEP
- Run a recall and safety report across every HEP manufacturer
- Watch product code HEP for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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